BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER

    MDR report key: 9324076 · Received November 14, 2019

    Report

    Report Number
    1218950-2019-08665
    Event Type
    Death
    Date Received
    November 14, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 7, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE FSE SPOKE TO THE CUSTOMER AND CONFIRMED THAT THE CUSTOMER HAD THE ALARMS CONFIGURED TO BE YELLOW, AND THEY WANTED THEM TO NOW BE RED. THERE WAS NO DELAY IN TREATMENT OF THE PATIENT. THE CUSTOMER DOES NOT FEEL THAT ALARMS WERE NOT ADDRESSED APPROPRIATELY, AS CONFIGURED. THE FSE WAS NOT ABLE TO CHANGE THE ALARM CONFIGURATION. THE R AND T PVC YELLOW ARRHYTHMIA ALARMS PRIORITY CANNOT BE CHANGED. THIS INFORMATION WAS PROVIDED TO THE CUSTOMER. THERE HAVE BEEN NO SUBSEQUENT CALLS LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. THERE WAS NO PRODUCT MALFUNCTION. THE DEVICE ALARMED APPROPRIATELY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PVC R-SU-T ALARM IS YELLOW. ONE PATIENT HAD VARIOUS PVC R SUT ALARMS AND A PACEMAKER ALARM; ALL ALARMS WERE HANDLED. THE PATIENT THEN DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116456 INTELLIVUE INFORMATION CENTER CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3150

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death